Regulation (EU) 2022/123 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices

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Series Details L 20, Pages 1-37
Publication Date 31/01/2022
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Summary:

Regulation (EU) 2022/123 - formally signed by the co-legislators on 25 January 2022 - aimed at reinforcing the mandate of the European Medicines Agency (EMA) when it comes to crisis preparedness and management for medicinal products and medical devices. This is a text with EEA relevance.

Further information:

The COVID-19 (coronavirus) pandemic highlighted the limited ability of the European Union (EU) to coordinate work to ensure the availability of medicinal products and medical devices and facilitate their development. It became clear that the EMA requires a framework to be deployed in preparation for and during public health emergencies and other major events to improve the EU's capacity to react quickly, efficiently, and in a coordinated manner to such emergencies. The general objectives of the legislative proposal are to:

  1. ensure a high level of human health protection by strengthening the Union’s ability to manage and respond to public health emergencies, which have an impact on medicinal products and medical devices;
  2. contribute to ensuring the smooth functioning of the internal market for such products during public health emergencies.

It was tabled by the European Commission on 11 November 2020, alongside a Communication setting out the first elements of a European Health Union. The Council of the European Union adopted its general approach on 15 June 2021, followed by the plenary of the European Parliament on 8 July. An informal agreement between the co-legislators on a compromise text was reached on 28 October. This was endorsed by the Parliament on 20 January 2022 and by the Council on 25 January. The Act was signed by the co-legislators on that same day and published in the Official Journal on 31 January 2022.

Source Link http://data.europa.eu/eli/reg/2022/123/oj
Related Links
Commentary and Analysis
European Patients Forum: Public consultation on European Medicines Agency – strengthened role to address public health emergencies (31 January 2021) https://www.eu-patient.eu/globalassets/0.-epf-consultation-response---ema_final.pdf
AESGP: Position Paper, 04/02/2021: Position on a reinforced EMA mandate (European Health Union) https://aesgp.eu/articles/position-on-a-reinforced-ema-mandate-european-health-union
BEUC: Position Paper, 12/04/2021: A More Powerful EMA to Better Protect Consumers in Crisis Times https://www.beuc.eu/publications/beuc-x-2021-033_a_more_powerful_ema_to_better_protect_consumers_in_crisis_times.pdf
EPRS: At a Glance, July 2021: European Medicines Agency mandate extension https://www.europarl.europa.eu/thinktank/en/document.html?reference=EPRS_ATA(2021)690694
BEUC: Press Release, 08/07/2021: EU Parliament supports reinforced role for European Medicines Agency in benefit to consumers https://www.beuc.eu/publications/eu-parliament-supports-reinforced-role-european-medicines-agency-benefit-consumers/html
BEUC: Press Release, 28/10/2021: Beefed-up role for European Medicines Agency to reduce risk of medicine shortages https://www.beuc.eu/publications/beefed-role-european-medicines-agency-reduce-risk-medicine-shortages/html
EPRS: At a Glance, January 2022: Reinforced role for European Medicines Agency https://www.europarl.europa.eu/thinktank/en/document/EPRS_ATA(2022)698871
BEUC: Press Release, 20/01/2022: Campaign to limit medicine shortages gets boost with new European Medicines Agency role https://www.beuc.eu/publications/campaign-limit-medicine-shortages-gets-boost-new-european-medicines-agency-role/html

News
EurActiv, 16/06/2021: EU health ministers back stronger pandemic role for EMA https://www.euractiv.com/section/eu-council-presidency/news/eu-health-ministers-back-stronger-pandemic-role-for-ema/
EurActiv, 13/07/2021: Reform of EU medicines agency: Where do EU institutions stand? https://www.euractiv.com/section/health-consumers/news/reform-of-eu-medicines-agency-where-do-eu-institutions-stand/
EurActiv, 19/07/2021: EU presidency expects solid results on health union package https://www.euractiv.com/section/eu-council-presidency/news/eu-presidency-expects-solid-results-on-health-union-package/
Politico, 01/09/2021: Europe’s ‘Health Union’ prepares for its first feeble steps https://www.politico.eu/article/european-health-union-coronavirus-ema-hera-barda/

Official
EUR-LEX: COM(2020)725: Proposal for a Regulation on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=COM:2020:725:FIN
European Parliament: Legislative Observatory: Procedure File for Proposal on European Medicines Agency (2020/0321(COD)) https://oeil.secure.europarl.europa.eu/oeil/popups/ficheprocedure.do?lang=en&reference=2020/0321(COD)
European Parliament: Legislative Train Schedule: Extension of the mandate of the European Medicines Agency (EMA) https://www.europarl.europa.eu/legislative-train/theme-promoting-our-european-way-of-life/file-ema-mandate-extension
Official Website of the European Medicines Agency https://www.ema.europa.eu/en
European Commission: Priorities 2019-2024: European Health Union https://ec.europa.eu/info/strategy/priorities-2019-2024/promoting-our-european-way-life/european-health-union_en
General Secretariat of the Council: Policies: Protecting Europeans against cross-border health threats https://www.consilium.europa.eu/en/policies/protecting-against-cross-border-health-threats/
European Commission: Press Release, 11/11/2020: Building a European Health Union: Stronger crisis preparedness and response for Europe https://ec.europa.eu/commission/presscorner/detail/en/ip_20_2041
European Commission: Questions and Answers: Building a European Health Union: Stronger crisis preparedness and response for Europe (11 November 2020) https://ec.europa.eu/commission/presscorner/detail/en/qanda_20_2042
European Commission: Remarks by Commissioner Stella Kyriakides at the press conference on Building a European Health Union (11 November 2020) https://ec.europa.eu/commission/presscorner/detail/en/speech_20_2090
Council of the European Union: Press Release, 15/06/2021: Council agreement paves way to reinforce European Medicines Agency https://www.consilium.europa.eu/en/press/press-releases/2021/06/15/council-agreement-paves-way-to-reinforce-european-medicines-agency/
European Parliament: Press Release, 22/06/2021: COVID-19 lessons learned: stronger role for EU medicines regulator https://www.europarl.europa.eu/news/en/press-room/20210617IPR06466/
S&D Group: Newsroom, 22/06/2021: S&Ds: a stronger European Medicine Agency brings the creation of a Health Union closer https://www.socialistsanddemocrats.eu/newsroom/sds-stronger-european-medicine-agency-brings-creation-health-union-closer
European Parliament: Press Release, 08/07/2021: Reinforcing the mandate for EU medicines regulator https://www.europarl.europa.eu/news/en/press-room/20210701IPR07513/
European Commission: Press Release, 28/10/2021: European Health Union: Commission welcomes agreement on a stronger European Medicines Agency https://ec.europa.eu/commission/presscorner/detail/en/ip_21_5599
Renew Europe EP Group: Newsroom, 19/01/2022: An updated mandate for the European Medicines Agency enhances preparedness for future health emergencies https://www.reneweuropegroup.eu/news/2022-01-19/an-updated-mandate-for-the-european-medicines-agency-enhances-preparedness-for-future-health-emergencies
European Parliament: Press Release, 20/01/2022: Health Union: a stronger role for the European Medicines Agency https://www.europarl.europa.eu/news/en/press-room/20220114IPR21015/
European Commission: Press Release, 25/01/2022: European Health Union: a stronger role for the European Medicines Agency https://ec.europa.eu/commission/presscorner/detail/en/ip_22_543
EU EMA: News, 31/01/2022: A stronger role for EMA https://www.ema.europa.eu/en/news/stronger-role-ema

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